This pivotal announcement is just what the doctor ordered..
CE Mark should not be taken lightly as it is extremely difficult to obtain a class 2 medical device approval especially Within the new regulations and the environment in which we were applying in. This was one of the most tedious and time-consuming times to apply for CE certification but we pulled through and got it in the end... So happy for us all definitely celebrating tonight...
Adult submissions are now forthcoming and we know the results were even better than the results presented during the breathe easy study for kids. We even had a larger test subject group of over 900 subjects from memory... IMO adult CE clearance is a SHOO-IN.. TGA is more or less a rubber stamp! Especially with CE under our belts.. the markets should look at also pricing in Singapore and Canadian clearance now also...
We know that our CEO Tony Keating has gone to China twice already, very recently, most probably talking to potential partner's there once we obtain TGA CLEARANCE. It takes around 45 days for TGA clearance and more than 90% of companies are CLEARED by the TGA if with have CE clearance..
So CE not only test the safety of the device but also tests the efficiency, they check to make sure that it actually does what it is supposed to do, substantiating ResApp's claims.. FDA will also check these two points as well as highlighting the benefits of adding such a tool into the medical sphere. RAP holds many benefits to add to the healthcare industry not only within a hospital setting within triage or at a doctor's office but especially during a telehealth consultation where there is currently no alternative for diagnosing respiratory disease in a similar fashion to that of a doctor with a stethoscope with an accuracy of less than 70%, 68.3% to be exact and this was discovered during the SmartCough-C2 trials and doctors accuracy using a stethoscope is published in various medical journals our accuracy levels are much greater than this from our double-blind clinical trials here in Australia and in the USA during the smartcough see to study we outperformed doctors results with three of the main respiratory diseases studied and they were using a whole range of tests not just a stethoscope.
We have a very unique device here and RAP is looking at charging between $5 to $10 per use, we know that 30 to 40% of all visits to a doctor are respiratory-related. We can now start talking numbers and potential earnings because ship just got real folks... telehealth is no doubt on the rise and this tool is going to fit beautifully with in this area as well as in other areas outside of telehealth...
All the very best to all and congratulations once again...
Cheers
Red bar
RAP Price at posting:
19.0¢ Sentiment: Buy Disclosure: Held
